CN109475414A - System and method for crimping prosthetic valve - Google Patents

Abstract

Disclose the embodiment of the crimping device for crimping radially distensible and compression prosthetic valve.Crimping device may include shell, and shell is configured as receiving the prosthetic valve for being in radial-expansion condition.Housing member may include funnel section and the outlet that is connected to funnel section.Crimping device also may include the actuator for being rotatably coupled to shell, wherein actuator causes prosthetic valve to move axially through funnel section and makes at least part of prosthetic valve radial compression and with engaging for funnel section relative to the rotation of shell, and leaves crimping device via outlet.

Description

System and method for crimping prosthetic valve

Technical field

This disclosure relates to for crimping prosthetic valve to be delivered to intracorporal system and method.

Background of invention

Human heart can suffer from various valve diseases.These valve diseases can lead to serious heart dysfunction, and most Manually valve replacement native valve is needed eventually.There are many known artificial valve and many known these artificial valves are planted Enter the intracorporal method of people.Due to the disadvantage of traditional open heart operations correlation, percutaneous and minimally invasive surgery method is causing people Great attention.In a kind of technology, prosthetic valve is configured as being inserted by conduit and is implanted into less invasive program.Example Such as, folding to be curled through conduit prosthetic heart valve to compressive state, and percutaneously imported on conduit with compressive state, And functional dimension is expanded in required position by balloon inflation or by using self expandable frame or bracket.

Prosthetic valve for this program may include can radial folding and expansion frame, the leaflet of prosthetic valve can To be couple on the frame.Leaflet is usually made of biomaterial, such as pericardium heart valve or the valve of harvest.In order to after deployment Function is improved, it is often desirable that these valves saved in solution with opening the diameter packaging of (that is, expansion) and being stored in, until Valve is mounted on delivery apparatus for when being implanted into.Use this program, it may be necessary to which a few minutes in situations in the surgery room will before implantation Valve curling, so that eliminating manufacturer carries out pre-crimped.Therefore, present many crimping devices are as disposable attachment and valve It is transported together with delivery system, to increase the portable importance of this crimping device.

In general, conventional crimping device is operated by one of two methods.In one approach, bracket passes through taper Bracket is compressed to small diameter by surface drive, conical surface.For example, static conical pipe can pass through on bracket, to subtract Its small diameter.This method has the self expandable metal framework being easily deformed (for example, the frame made of Nitinol commonly used in curling Frame) prosthetic valve.Can self expandable prosthetic valve usually from the sheath that the conical pipe of crimping device is pushed into delivery device, sheath Prosthetic valve is maintained at radial compression by pipe.Second of coiling method generates the cylinder of changeable diameter using curling pincers Shape surface.This method has plasticity expansion frame (for example, the frame made of stainless steel or cochrome commonly used in curling Frame) prosthetic valve.

Can self expandable prosthetic valve usually have from frame extend multiple connecting components, these connecting components formed and pass Send the releasable connection of device far end.Once prosthetic valve is deployed in patient's body from sheath, doctor, which can discharge, to be passed Send the connection between equipment and the connecting component of prosthetic valve.Curling can self expandable prosthetic valve challenge involve doctor be easy and Rapidly prosthetic valve is crimped and is loaded into the sheath of delivery device while setting the connecting component of prosthetic valve with delivering The ability of standby mating connection member align and connection.Therefore, there is still a need for a kind of improved crimping device, solves existing skill These and other disadvantage in art.

Summary of the invention

Illustrative embodiments for crimping the crimping device of radially distensible and compression prosthetic valve may include shell Body, the shell are configured as receiving the prosthetic valve for being in radial-expansion condition.Housing member may include funnel section and and funnel The outlet of Duan Liantong.Crimping device may also include the actuator for being rotatably coupled to shell, and wherein actuator is relative to shell Rotation cause prosthetic valve to move axially by funnel section so that at least part of prosthetic valve with funnel section by nibbling It closes and radial compression and leaves crimping device via outlet.The rotation of actuator can cause actuator to move axially on shell.

Some embodiments of crimping device can also include stick member, which is configured as prosthetic valve Against in the housing, wherein the rotation of actuator causes stick member to move axially relative to shell, to push prosthetic valve Pass through shell.Stick member may include inner cavity, which includes multiple ribs, and multiple rib is configured as connecing during radial compression Touch prosthetic valve.Additionally and/or alternatively, stick member may include annular groove, which is configured as receiving The end of prosthetic valve.Stick member can be rotatably coupled to actuator, so that actuator can be revolved relative to stick member Turn.Stick member may include the releasably locking component for releasably engaging with actuator.

In some embodiments of crimping device, shell may include two or more housing units, when assembling forms shell When body, two or more housing units form substantial cylindrical.Holding member can be configured to two or more shell groups Part is releasably held together.

It additionally and/or alternatively, can for crimping radially distensible and compression prosthetic valve exemplary crimping device With comprising the shell with outlet, which is configured as receiving the prosthetic valve for being in radial-expansion condition；And phase For the stick member that shell is axially movable, wherein stick member is configured as against the end of prosthetic valve, and push rod Component causes prosthetic valve radial compression and prosthetic valve to configure axis with the delivering of radial compression relative to the axial movement of shell Pass through outlet to movement.Crimping device also may include actuator, which can rotate relative to shell and stick member, to draw Stick member is played to move axially relative to shell.

In some embodiments, the inner surface of shell may include multiple ribs, and multiple ribs are configured as receiving in radial The prosthetic valve of expansion state.Additionally and/or alternatively, stick member can further comprise multiple fins, multiple fin quilts It is arranged between multiple ribs, and is configured as slidably engaging multiple ribs during stick member moves axially.Housing member It also may include the conical inboard wall for terminating at outlet.Inner wall can cause valve prostheses relative to during shell axial movement in stick member Film radial compression.In some embodiments, stick member can be rotatably coupled to actuator, so that actuator can be opposite It is rotated in stick member.

Illustrative methods for crimping prosthetic valve may include the shell rotation crimping device relative to crimping device Actuator, wherein shell includes the funnel with the outlet of crimping device, and engages prosthetic valve slidably with funnel, So that at least part radial compression of prosthetic valve and leaving crimping device via outlet.In some embodiments, the party Method can also be comprising releasing prosthetic valve from the outlet of crimping device and being advanced in the sheath of delivery device.

In some embodiments, funnel may include towards crimping device longitudinal axis extend radially inwardly it is multiple Rib, and coiling method can further include and be aligned at least part of the frame of prosthetic valve in multiple ribs.Shell can Comprising two or more housing units, wherein each housing unit includes a part of funnel.In some embodiments, should Method, which can further include, to be assembled two or more housing units before crimping prosthetic valve and coaxially places shell Around delivery device.Additionally and/or alternatively, this method may include dismount two or more housing units and by they It is removed from delivery device.

In terms of the detailed description below with reference to the accompanying drawings carried out, aforementioned and other target, component and advantage of the invention will become It must become apparent from.

Detailed description of the invention

Fig. 1 is the cross section view of exemplary crimping device and prosthetic valve, shows prosthetic valve and is curled and is loaded into On delivery device.

Fig. 2 is the section partial exploded view of the crimping device of Fig. 1.

Fig. 3 is the side view of the housing unit of the crimping device of Fig. 1.

Fig. 4 is the cross section view along the housing unit of the line 4-4 of Fig. 3 Fig. 3 intercepted.

Fig. 5 is the perspective view of the housing unit of Fig. 3.

Fig. 6 is the perspective view of another housing unit, and the housing unit is complementary with housing unit shown in fig. 5.

Fig. 7 is the perspective view of the retaining ring of the crimping device of Fig. 1.

Fig. 8 is the perspective view of the shell assembly of the crimping device of Fig. 1 comprising component shown in Fig. 5-7.

Fig. 9 is the perspective view of the actuator of the crimping device of Fig. 1.

Figure 10 be along 10-10 interception Fig. 9 actuator cross section view.

Figure 11 is the perspective view of the valve supporter (holder) of the crimping device of Fig. 1.

Figure 12 be along 12-12 interception Figure 11 valve supporter cross section view.

Figure 13 is the cross section view according to the crimping device of another embodiment.

Figure 14 is the sectional exploded view according to the crimping device of another embodiment.

Figure 15 is the section assembling figure of the crimping device of Figure 14.

Figure 16 is the top perspective view of the shell of the crimping device of Figure 14.

Figure 17 is the top perspective view of the stick member of the crimping device of Figure 14.

Figure 18 is the sectional stereogram of the crimping device of Figure 14.

Figure 19 is the crimping device of Figure 14 and the sectional stereogram of the prosthetic valve by crimping device curling.

Figure 20 is the side view that the exemplary prosthetic valve of any crimping device curling disclosed herein can be used.

Figure 21 is the side view of the distal portions of exemplary delivery equipment, which can be used for delivering and implantation figure 20 prosthetic valve.

Specific embodiment

For the purpose of the description, this document describes some aspects of disclosure embodiment, advantage and novel components.Knot Close component, entirety, characteristic, compound, chemical part or the group of certain aspects of the present disclosure, embodiment or embodiment description It will be appreciated that can be applied to any other aspect, embodiment or embodiment described herein, unless being compatible with.This explanation All components disclosed in book (including any appended claims, abstract and attached drawing) and/or so disclosed any method Or all steps of process can be combined in any combination, in addition to component as wherein at least some and/or step are mutual Except the combination of reprimand.The present invention extends to disclosed in this specification (including any appended claims, abstract and attached drawing) Any novel one in component or any novel combination, or extend to the step of so disclosed any method or process Any novel one or any novel combination in rapid.

Although presenting for convenience, some disclosed method operations are described in a particular order, but it is to be understood that this Kind describing mode, which is covered, to be rearranged, unless language-specific requires specific sequence.For example, the operation of sequence description can be one It rearranges or is performed simultaneously in a little situations.In addition, for simplicity, attached drawing can not show disclosed method in combination with it The various modes that its method uses.

As used herein, term " one (a) ", " one (an) " and " at least one (at least one) " include one or Multiple specified elements.That is, if there is two specific factors, then there is also therefore have " one to one in these elements It is a " element.Term " multiple " and " a plurality of " mean two or more specified elements.

As used herein, it is meant in listed elements in the term "and/or" of element list most used between latter two Any one or more.For example, phrase " A, B and/or C " mean " A ", " B ", " C ", " A and B ", " A and C ", " B and C " or " A, B and C ".

As used herein, term " coupling (coupled) ", which is generally meant, physically couples or engages (linked), and Be not excluded in the case where lacking specific opposite language coupling item between there are intermediate elements.

Fig. 1 is shown for crimping prosthetic valve and other rollable, implantable medical device (such as brackets, transplanting Object etc.) exemplary system.Exemplary system includes crimping device 10 and radially distensible and compression prosthetic valve 12, display Prosthetic valve 12 is located in crimping device 10.Crimping device 10 is configured as the diameter of prosthetic valve 12 from fully expanded configuration The delivering for being reduced to radial compression is configured to be delivered to patient's body.Prosthetic valve 12 is shown schematically for showing in Fig. 1 Example purpose.Figure 20 is showing in more detail for the exemplary prosthetic valve that can be used together with any crimping device disclosed herein Example.

Exemplary system shown in Fig. 1 can also include delivery device 14 or part of it.Delivery device may include interior Axis or conduit 15 and outer sheath 16, outer sheath 16 are sized to for prosthetic valve 12 to be maintained at radial compression configuration, with It is delivered to patient's body.Prosthetic valve 12 may include it is any can radial folding and expansion prosthetic valve, such as prosthetic heart valve Film.Prosthetic valve 12 can radial folding and expansion between expansion configuration and delivering configuration.Prosthetic valve can be can be from expansion The expansion of open or plasticity.Can self expandable valve can have the frame formed by self expandable metal (for example, Nitinol).It can Plastic expansion valve can have the frame formed by plastically deformable metal (such as stainless steel or cochrome).

It, can be by prosthetic valve 12 from curling after prosthetic valve 12 is crimped on delivery device 14 in delivering configuration Device 10 removes.In some embodiments, prosthetic valve 12 and delivery device 14 can promote the outlet by crimping device 10, So that crimping device 10 is held in position in delivery device 14 around the part in 12 distal side of prosthetic valve.In other embodiment In, crimping device 10 or its component can be configured to separation member or opening, as clam shell, so that crimping device 10 can be from 12 lateral removal of delivery device 14 and prosthetic valve, as described further below.Prosthetic valve 12 is removed from crimping device 10 Later, prosthetic valve 12 and delivery device 14 can be imported into patient's body.

As shown in Fig. 2, the part of crimping device 10 can be for example removably coupled with another via screw thread engagement.For example, Crimping device 10 in exemplified embodiment includes shell 18, and shell 18 is threadingly coupled to activate with rotatable knob form Device 20.Crimping device 10 also may include can relative to housing member 18 move axially stick member or valve supporter 22 ( Referred to as base component 22).

What Fig. 3-6 was shown in which can to position prosthetic valve 12 is generally rigid shell 18.In exemplified embodiment Shell 18 include assembly, which separately includes the first and second separable housing unit 19a and 19b.Each shell Component 19a, 19b may include male thread portion 24, outlet 28 and inner funnel section 32 at proximal end 30, and male thread portion 24 is included in External screw thread on the outer surface of housing unit adjacent distal end 26.The funnel section 32 of each housing unit 19a, 19b include to terminate at Export the inner conical wall 34 at 28.For example, each funnel section 32 can be from the middle section 36 of neighbouring housing unit 19a, 19b Second small diameter of the first larger diameter possibly tapered to neighbouring outlet 28.The diameter of outlet 28 can be approximately in radial pressure The desired diameter of prosthetic valve 12 in the delivering configuration of contracting.In some embodiments, outlet 28 can be at proximal end 30 and outer Edge point 29 flushes, but in other embodiments, and outlet 28 can divide 29 recess relative to edge or extend beyond edge point 29.

Each housing unit 19a, 19b may include semicylinder.When putting together, housing unit 19a, 19b shape At general cylindrical or tubular form.Housing unit 19a, 19b may include component, the assembling of component assisting user Housing unit 19a, 19b.In exemplified embodiment, for example, first shell component 19a, which has, is formed in first shell group In the longitudinal edge of part 19a in the recess portion 62 (Fig. 5) being diametrically opposed to one another, and second shell component 19b has and is formed in second In the longitudinal edge of housing unit 19b in the protrusion 64 (Fig. 6) being diametrically opposed to one another.The size of recess portion 62, which is set, to be designed as working as Complementary protuberance 64 is received when housing unit 19a, 19b are put together.

In the assembled state, the external screw thread 24 of housing unit 19a, 19b is in alignment with each other to be formed in shell assembly 18 The continuous thread extended around outer surface.The external screw thread of shell assembly 18 is configured as matching with the internal screw thread 54 of actuator 20 It closes, to be generated between actuator 20 and shell assembly 18 opposite when actuator 20 is rotated relative to shell assembly 18 It is axially moved, as further discussed below.

When prosthetic valve is in curling, first shell component 19a and second shell component 19b can be in assembled states Under be maintained or lock together, then prosthetic valve be loaded on delivery device after be separated from each other, with promote will volume Bent device 10 is removed from delivery device 14.For example, as shown in figs. 2 and 7, crimping device 10 can also comprising holding member 38 ( Referred to as retaining ring), it is configured as surrounding housing unit 19a, 19b for example at the proximal end of housing unit 19a, 19b 30, and Releasedly housing unit 19a, 19b are locked or kept together.Holding member 38 may include grasping interface 40, in order to User grasps and uses.Grasping interface 40 may include for example multiple circumferentially spaced ribs 41.

Holding member 38 may include annular surface 56, and the size of annular surface 56 can be set in shell group It is slided on the proximal part of part 19a, 19b and forms frictional fit therewith, allow holding member during use by shell Component 19a, 19b are held together, but when needing to dismount shell assembly 18 and removing it from delivery device 14, are used Person can easily remove it from housing unit 19a, 19b.Holding member 38 may include one or more recesses 58, such as Two as shown in Figure 7 in the recess 58 being diametrically opposed to one another.Recess 58 can be configured to receive from housing unit 19a, 19b The complementary protuberance 60 that outer surface extends, to assist that holding member 38 is maintained to be in appropriate location during use.Fig. 4 show from The protrusion 60 that the outer cylinder surface of first shell component 19a extends.Second shell component 19b may include being located at and first shell Protrusion on component 19a is in the same projection 60 being diametrically opposed to one another.

In some embodiments, other technologies or mechanism can be used, holding member 38 is fixed on housing unit On 19a, 19b.For example, the recess 58 or other parts of holding member 38 can be configured to it is corresponding to housing unit 19a, 19b Part forms and snaps fit attachment.Optionally, holding member 38 can have threaded portion (for example, internal screw thread), threaded portion Engage the respective threaded (for example, external screw thread) on housing unit 19a, 19b.

In alternate embodiments, housing unit 19a, 19b may include releasable cooperation locking member, be configured To be engaged with each other and keeping housing unit 19a, 19b to be in their assembled state, without the use of individual holding member 38.Example Such as, first shell component 19a, which can have, forms the releasable company of being clasped to the corresponding component of second shell component 19b The component connect.

In alternate embodiments, shell assembly 18 may include single cylindrical housings component or component, rather than Multiple separable components.In such optional embodiment, holding member 38 will not needed.In another optional embodiment In, shell assembly 18 may include more than two housing unit, for example, three, four or more can be assembled into cylindrical shape The separable housing unit of formula.

As described above, crimping device 10 can also include actuator 20 and valve supporter 22.The internal screw thread of actuator 20 54 engage with the external screw thread 24 of shell assembly 18 so that rotation of the actuator 20 relative to shell assembly 18 in one direction Quote actuator 20 to move relative to the direction that arrow 88 indicates along Fig. 1 of shell assembly 18 to nearside.20 edge of actuator The rotation of opposite direction causes actuator 20 distad to move relative to the direction that arrow 90 indicates along Fig. 1 of shell assembly 18 It is dynamic.

As used herein, term " nearside " or refer to " Xiang nearside " closer to using delivery device 14 user or along Towards the direction of the user using delivery device 14.Therefore, hand of the proximal direction that arrow 88 indicates towards delivery device 14 Handle (not shown) and user.As used herein, term " distal side " or " distad " refer to from using using for delivery device 14 Person direction and user farther or along the separate user using delivery device 14.Therefore, the distal direction that arrow 90 indicates Handle and user far from delivery device 14 extend.

In the exemplary embodiment, crimping device 10 is disposed on delivery device 14 at the position in 16 distal side of sheath, And make actuator 20 limit the distal end of crimping device 10, and holding member 38 limits the proximal end of crimping device 10.However, answering Work as understanding, crimping device 10 can be placed on delivery device 14 at the proximal position of the proximal open of sheath with reverse position, Wherein actuator 20 limits the proximal end of crimping device 10, and holding member 38 limits the distal end of crimping device 10.Therefore, Ke Yili Solution is for side using these terms when term " nearside " and " distal side " are for describing component and its operation of crimping device Just it for the sake of, does not need crimping device and is oriented relative to certain of delivery device or user.

As shown in FIG. 11 and 12, valve supporter 22 can be generic cylindrical, and be sized to match It closes in the axially extending hole 42 of shell assembly 18.Valve supporter 22 is configured as maintaining at least one of prosthetic valve 12 Point, and 12 through hole 42 of prosthetic valve and funnel section 32 are axially pushed, to realize the curling of prosthetic valve 12.As indicated, valve Film supporter 22 may include annular recess portion 44, the engagement of annular recess portion 44, against or receive the first end of prosthetic valve 12 Portion 46.Annular recess 44 may include annular lip 48, and annular lip 48 is configured as tieing up the first end 46 of prosthetic valve 12 It holds in recess portion 44.

Annular recess 44 can in the proximal part 68 for being formed in valve supporter 22 relatively major lumen or hole 66 be connected to. The wall of chamber 66 can be formed with multiple circumferentially spaced ribs 70, and rib 70 longitudinally extends along the inner surface of chamber 66 and from the inner surface of chamber 66 It extends radially inwardly.Rib 70 can help supporting prostheses valve 12, so that the valve prostheses during the radial compression of prosthetic valve 12 The axial deformation of film 12 is smaller.Rib 70 can further assist appropriate placement of the prosthetic valve 12 in crimping device 10.Multiple ribs 70 quantity can change according to the type and/or size for the prosthetic valve to be crimped.

As further shown in Fig. 1 and 12, the distal portions 72 of valve supporter 22 can have axially extending hole 82, hole 82 are connected to the chamber 66 in the proximal part 68 of valve supporter.In this way, hole 82 and chamber 66 form axially extending lead to Road or cavity, channel or cavity extend completely through valve supporter 22, to allow delivery catheter 14 to be inserted through valve branch Holder 22.

Valve supporter 22 can be rotatably coupled to actuator 20, to allow actuator 20 relative to valve supporter 22 rotation, and in actuator rotation, realize the axis of actuator 20 and valve supporter 22 relative to shell assembly 18 To movement.For this purpose, the distal portions 72 of valve supporter 22 can be formed with one or more releasably locking components 74 (for example, For two in the locking member 74 being diametrically opposed to one another in exemplified embodiment), it is configured as being releasably engageable cause Dynamic device 20.For example, such as Fig. 1 institute best image, each locking member 74 may include deflectable antelabium 76 and recess or groove 78, recessed Mouth or groove 78 are sized to receive the annular flange 80 of actuator 20 inwardly changed.Antelabium 76 is being pressed against flange It can be deflected inward when on 80, this allows flange 80 to slide into groove 78, to form card between flange 80 and locking member 74 Button is cooperatively connected.

Relative to flange 80, groove 78 can be slightly oversized, to allow in actuator 20 relative to valve supporter When 22 rotation, flange 80 rotates in groove 78.Since the screw thread of actuator 20 and shell assembly 18 engages, actuator 20 Rotation effectively causes moving to axial between actuator 20 and shell assembly 18.The flange 80 engaged with groove 78 will cause The axial movement of dynamic device 20 is transmitted to valve supporter 22, so that the axial movement of actuator 20 effectively makes 22 phase of valve supporter Shell assembly 18 is moved axially in same direction.Prosthetic valve 12 is axially forced through shell in turn by valve supporter 22 Body assembly 18.Therefore, actuator 20 can promote valve supporter 22 against valve prostheses relative to the rotation of shell assembly 18 The first end 46 of film 12, so that tapered wall 34 of the prosthetic valve 12 against funnel 32 is forced, so as to cause prosthetic valve 12 in quilt It is forced through funnel 32 and outward by radial compression when exit opening 28.

If desired, actuator 20 can cross the radially inner most of flange 80 by pressing inward against the antelabium 76 of locking member Edge and removed from valve supporter 22, this allows actuator 20 axially to slide away from the distal portions 72 of valve supporter 22 And it is detached from and is engaged with the distal portions 72 of valve supporter 22.In other embodiments, actuator 20 is not needed from valve It can be removed on supporter 22, but valve supporter 22 can be permanently coupled to, but allow in other ways as described above Actuator 20 and valve supporter 22 relative rotation.

As shown in figure 11, valve supporter 22 can have one or more external ribs longitudinally extended or protrusion 84 (in institute For two in the rib 84 being diametrically opposed to one another in exemplary embodiment).External rib 84 is sized to receive in each shell (referring to Fig. 3) in respective longitudinal slot 86 in body component 19a, 19b.Although illustrating only first shell component 19a's in Fig. 3 Slot 86, but second shell component 19b has with the slot in first shell component 19a in the same groove 86 being diametrically opposed to one another.Rib 84 It can be used for being aligned valve supporter 22 in shell assembly 18 in the engagement in slot 86, and prevent from rotating in actuator 20 When, any rotation of the valve supporter 22 relative to actuator 20 and shell assembly 18.

The screw thread of actuator 20 and shell assembly 18, which engages, allows user to accurately control the propulsion of prosthetic valve 12 Leave the radial compression of crimping device 10 and/or prosthetic valve 12.Crimping device 10 also allows 10 He of one man operation crimping device For crimping and loading repeatable, the predictable program of prosthetic valve 12.Some embodiments of prosthetic valve 12 can be with Including formed with the component of delivery device 14 releasable connection connecting component (connecting component be located at prosthetic valve and valve The opposite end in the end that film supporter 22 engages) (for example, with reference to the company for the prosthetic valve 300 being further detailed below Connect arm 312).The connecting component of necessary radial compression prosthetic valve, while keeping the component rotation into alignment with delivery device. Crimping device 10 allows individual operator to control the curling of prosthetic valve, while the connecting component of prosthetic valve being kept to set with delivering Standby component rotation into alignment.When the outlet 28 of crimping device 10 is left in prosthetic valve propulsion, operator can be by prosthese The connecting component of valve is connected to the component of delivery device.

In the embodiment shown in fig. 3, for example, prosthetic valve 12 can be promoted is gone forward side by side by the outlet 28 of crimping device 10 Enter in the sheath 16 of delivery device 14.Sheath 16 can be tubular structure, be configured as accommodating the prosthese in delivering configuration Valve 12.It then, can be by crimping device by distad skidding off (along the direction of arrow 90) crimping device 10 from inner shaft 15 10 remove from delivery device 14.

In some embodiments, delivery device 14 may include the nose cone or tip portion in the far-end of inner shaft 15, It can prevent from removing crimping device 10 and distad skidding off crimping device 10 from inner shaft 15.In this case, it crimps Device 10 can dismount in this way: rotate in mutually opposite directions actuator 20 to cause actuator 20 relative to shell assembly 18 It is distally moved (along the direction of arrow 90), until actuator 20 is detached from shell assembly 18 and removes from shell assembly 18. Holding member 38 can be skidded off from the proximal end of shell assembly 18, then this allows first shell component 19a and second shell group Part 19b is laterally separated with delivery device 14 away from each other.Valve supporter 22 is preferably provided with sufficiently large cavity to set from delivering Standby 14 skid off, such as by distad sliding valve supporter 22 relative to inner shaft 15, until valve supporter 22 is set from delivering Standby distal end removes.

Delivery device 14 can be inserted into the vascular system of patient, and be used to pass through prosthetic valve 12 using routine techniques Skin is delivered to desired implantation position.The distal end of delivery device 14 is inserted into another dress for having been inserted into patient's body It sets, in guide sheath, to promote delivery device 14 being inserted into patient's body.

In some embodiments, the system comprising crimping device 10, delivery device 14 and prosthetic valve 12 can be wrapped It fills and is transported to end user from manufacturer, wherein prosthetic valve 12 is preloaded in the interior of the crimping device 10 assembled completely Portion, crimping device are coaxially mounted on delivery device.In some embodiments, system can also include aseptic packaging, Surround be mounted on the distal portions of delivery device crimping device 10, be preloaded in crimping device prosthetic valve 12, with And the only distal portions of entire delivery device 14 or the delivery device for being equipped with crimping device and prosthetic valve.In other embodiment party In formula, system can also include another device, as guide sheath is assisted once being had been loaded into sheath 16 with prosthetic valve It helps delivery device 14 is inserted into the patient.

In some embodiments, prosthetic valve 12 can in part, curling be matched before being assembled into crimping device 10 It sets.For example, another curling instrument can be used by 12 pre-crimped of prosthetic valve to portion before being assembled into crimping device 10 Divide curling configuration.In the curling configuration of part, the outer diameter of prosthetic valve 12 configures outer between the outer diameter of expansion configuration and delivering Between diameter.In some embodiments, the outer diameter that prosthetic valve 12 can have in the curling configuration of part is compared matches in expansion The outer diameter set closer to delivering configuration in outer diameter.For example, prosthetic valve 12 in the curling configuration of part can be with Crimp about the 75% of the mode that delivering configuration is configured to from expansion.Crimping device 10 be also configured to by prosthetic valve 12 from Expansion configuration curling is to delivering configuration, without first by 12 pre-crimped of prosthetic valve to middle section curling configuration.

Figure 13 shows the optional embodiment of crimping device 100, crimping device 100 include shell, valve supporter or Stick member 104 and actuator or knob 106.Shell may include single, substantial cylindrical structure.Optionally, shell It may include two or more separable housing units as described above.For example, shell may include first shell component 102 and second shell component (not shown).When assembled together, first shell component 102 and second shell component can be formed Substantial cylindrical or tubular form.First shell component and second shell component can include releasable cooperation sticking department Part, locking member are configured as being engaged with each other and housing unit are maintained at its assembled state.For example, each housing unit can be with Including the one or more fins 108 (being shown on first shell component 102 in Figure 13) extended from the proximal end of housing unit, example The fin 108 as in outlet 110 in two be diametrically opposed to one another on side.A fin on first shell component 102 108 may include threaded hole 112, and another fin 108 may include non-threaded holes 114.Non-threaded holes 114 can have ratio The big diameter of threaded hole 112.Threaded hole 112 can be configured as to be aligned with the non-threaded holes on the fin of second shell component, And non-threaded holes 114 can be configured as to be aligned with the threaded hole on the fin of second shell component (not shown).Screw thread spiral shell Nail or knob (not shown) can first pass through non-threaded holes, then pass through the threaded hole of the first and second housing units, by the One and second shell component combine and be releasably held together.

Figure 14-19 shows the optional embodiment of crimping device 200, and crimping device 200 includes shell 202, valve branch Holder or stick member 204 and rotary actuator or knob 206.Figure 14 is the exploded view of crimping device 200.Figure 15 is curling The section assembling figure of device 200.Shell 202 can have generally cylindrical shape, have the external thread part of distally part 210 Points 208 and along proximal part 220 funnel section 214, funnel section is connected to exit opening 212.In exemplified embodiment, Shell 202 includes single substantial cylindrical structure.However, in other embodiments, shell may include multiple separable The assembly of housing unit, as described in above in association with crimping device 10.

Funnel section 214 includes taper or infundibulate wall 216, wall 216 from the middle section 218 of neighbouring shell 202 first Second small diameter of the larger diameter possibly tapered at outlet 212.Shell 202 can also include the distal portions from shell 202 210 extend to the inner conical wall 222 of the distal end of approximate neighbouring funnel section 214.Inner conical wall 222 along from distal portions 210 to The direction of proximal part 220 is mobile, from the first larger diameter possibly tapered to the second small diameter.In the exemplary embodiment, Wall 222 is with the angle conical of longitudinal axis A relative to crimping device more smaller than funnel section, and funnel section is with steeper opposite In the angle conical of longitudinal axis A.In other embodiments, wall 222 can angle identical with funnel section 214 or with than The bigger angle conical of funnel section 214.

Wall 222 may include multiple circumferentially spaced ribs 224, and rib 224 longitudinally extends along a part or whole length of wall 222 And it is extended radially inwardly towards longitudinal axis A.The width (width is the size extended from wall 222 towards longitudinal axis A) of rib can be with Increase to the larger width of located adjacent proximal end part 220 from the smaller width of adjacent distal end part 210 along their length.Rib 224 for preventing or at least minimizing the axial deformation and/or assistance of the prosthetic valve 250 (referring to Figure 19) during radial compression The connecting component of prosthetic valve is aligned with the component of delivery device.

In a specific embodiment, rib 224 may also begin to prosthetic valve 250 from fully expanded diameter radial compression To the diameter of part curling, then prosthetic valve 250 enters funnel section 214, there then rolls up prosthetic valve 250 from part Bent diameter swirls are to the diameter crimped completely, to be loaded into delivery device.Therefore, in this way, shell 202 can have There are two crimping portion, the two crimping portions can crimp in different ratios because of the different taper angles of two parts Prosthetic valve.In exemplified embodiment, for example, wall 222 and rib 224 are with more smaller than funnel section 214 relative to longitudinal direction The angle conical of axis A, in this case, the first crimping portion (being limited by rib 224) is first by prosthetic valve curling the One amount, then further the second amount of curling, the second amount are greater than the first amount to the second crimping portion (being limited by funnel section 214).

As best shown in Figure 17, stick member 204 may include substantial cylindrical or tubular body 226, in proximal Annular flange 230 and from flange 230 extend multiple circumferentially spaced fins 228 radially extended.Fin 228 can be matched It is set between the rib 224 for being slidably disposed on shell 202, so that when stick member 204 is moved axially relative to shell 202 When, fin 228 slides between rib 224.As best shown in figure 18, each of fin 228 can have opens on the width The shape of angled section opened or widened radially extends far from annular flange 230, to correspond roughly to rib 224 Between spatial form.Annular flange 230 is configured as when pushing prosthetic valve by shell 202, against prosthetic valve 250 Approach end 232.

In alternate embodiments, stick member 204 can have annular recess (similar to the recess portion of valve supporter 22 44) or like, the component are configured as when prosthetic valve is pushed through shell 202, maintain or keep prosthetic valve End.

Actuator 206 can have the internal screw thread 234 for being configured as engagement 202 external screw thread 208 of shell, so that actuator 206 rotation causes actuator 206 to move axially along the length of shell 202.Actuator 206 can be around stick member 204 simultaneously It can be couple to stick member 204, so that the axial movement of actuator 206 is (by actuator 206 relative to 204 He of stick member The rotation of shell 202) cause stick member 204 accordingly to move axially through shell 202.For example, the main body of stick member 204 can It is formed with elastic locking part 238, elastic locking part 238 is configured as the radial flange inwardly changed with actuator 206 240 formation snap fit attachment.

Crimping device 200 can be used for crimping prosthetic valve 250 in such a way that above-mentioned combination crimping device 10 describes.In short It, prosthetic valve 250 is inserted into shell 202.Stick member 204 (it can be pre-assembled to actuator 206) is inserted into In shell 202, the approach end 232 of prosthetic valve 250 is engaged when so as on the outside that actuator 206 is screwed to shell 202.To the greatest extent Pipe is not shown, and shell 202, prosthetic valve 250, stick member 204 and actuator 206 can be coaxial around the axis of delivery device Ground positioning.When actuator 206 is rotated relative to shell 202, actuator 206 is moved axially along shell 202, pushes stick member 204 by shell 202, this pushes prosthetic valve 250 to pass through shell 202 in turn.When prosthetic valve 250 is pushed through tapered wall When section 222 and funnel section 214, prosthetic valve is radially compressed and is pushed outwards dynamic by outlet 212.In specific embodiment In, prosthetic valve 250 can be directly from the sheath (not shown) that crimping device 200 is pushed into delivery device.

Figure 20 is the side view that the exemplary prosthetic valve 300 of any crimping device curling disclosed herein can be used.It is false Body valve 300 includes radially distensible and compression metal framework 302, multiple leaflets in 302 braced frame of metal framework 304.Prosthetic valve 300 can also include containment member 306 (for example, fabric skirt), and containment member 306 is fixed on outside frame 302 And it is configured as forming sealing against native valve ring.In some embodiments, prosthetic valve 300 can self expandable, Wherein frame 302 is formed by self expandable metal (for example, Nitinol).

Frame 302 may include main body 303 and the first group of anchoring piece extended towards one another from the opposite segments of main body 303 308 and second group of anchoring piece 310.In a specific embodiment, prosthetic valve 300 is prosthetic mitral valve valve, and anchoring piece 308 are configured as helping for prosthetic valve 300 to be anchored in atrium sinistrum, and anchoring piece 310 is configured as helping valve prostheses Film 300 is anchored in left ventricle.The end opposite with anchoring piece 310 of frame 302 may include have enlarged end 314 multiple Linking arm 312.End 314 is configured as the component of engagement delivery device, with the shape between prosthetic valve and delivery device At releasable connection.

As described above, multiple ribs 224 facilitate the alignment of prosthetic valve 300.For example, prosthetic valve 300 can be filled in curling Interior alignment is set, so that one group or two groups of settings (such as figure between multiple ribs in first group and second group of anchoring piece 308 and 310 In 19 shown in second group of anchoring piece 310), so that it is guaranteed that enlarged end 314 is positioned for the auxiliary section with delivery device Part engagement, to form releasable connection between prosthetic valve and delivery device.When prosthetic valve is pushed out outlet 212, Second group of anchoring piece 310 can radial compression against the frame 302 of prosthetic valve 300 main body 303.In alternate embodiments, The front end 241 (Figure 19) of funnel section 214 may be adapted to cause anchoring piece 310 when the movement of prosthetic valve 300 is by funnel section 214 The substantially straight configuration for extending 180 degree from main body 303 is bent to far from main body 303.

Figure 21 shows the distal portions of exemplary delivery equipment 400, and delivery device 400 can be used for prosthetic valve 300 It delivers and is implanted into the patient.Any crimping device disclosed herein can be used for crimping prosthetic valve 300 and be loaded into On delivery device 400.As indicated, delivery device 400 generally comprises outer sheath 402, the coaxial first axle for extending sheath 402 404 and coaxial the second axis 406 for extending through first axle 404.Nose cone 408 could attach to the distal portions of the second axis 406.Although It is not shown, the proximal part of sheath 402, first axle 404 and the second axis 406 can be couple to handle, and every in these components One can move axially in relation to each other.

Valve holding member 410 may be coupled to the distal portions of first axle 404, and may include multiple circumferentially-spaced Slot 412, slot 412 be sized to receive prosthetic valve 300 linking arm 312.In curly course, valve keeps structure Part 410 may initially reside in outside sheath 402.When prosthetic valve 300 is initially pushed out the outlet 212 of crimping device 200, connection Arm 312 can be placed in the respective slot 412 of valve holding member 410.Enlarged end 314 can be positioned on the ring of adjacent grooves 412 In shape slot 414, to prevent prosthetic valve and valve holding member axial separation.

When prosthetic valve is further promoted from crimping device, sheath 402 can be in valve holding member 410 and prosthetic valve It is distally advanced on 300, so that prosthetic valve delivery device 400 can be used to deliver and be implanted into the patient.By delivery device Desired implant site is located in (for example, primary bicuspid valve valve in the vascular system of 400 insertion patients and by distal portions Film) at or its adjacent place after, sheath 402 can to proximal retraction with from sheath 402 dispose prosthetic valve 300, allow prosthese Valve is expanded under the elasticity of its own.When sheath 402 crosses valve holding member 410 to proximal retraction, linking arm 312 can Their engaging with slot 412 are radially expanding away from, are coupled so that prosthetic valve and delivery device be made to disengage.

In view of the principle for disclosing invention being applied in many possible embodiments, it should be appreciated that shown The embodiment of example is only preferred embodiment of the invention, without that should be viewed as a limitation the scope of the present invention.On the contrary, of the invention Range be defined by the following claims.Therefore, we be claimed fall into it is complete in these scope and spirit of the claims Invention of the portion as us.

Claims (20)

1. a kind of for crimping the crimping device of radially distensible and compression prosthetic valve, the crimping device includes:

Shell, the shell are configured as receiving the prosthetic valve for being in radial-expansion condition, and the housing member includes funnel Section and the outlet being connected to the funnel section；And

Actuator, the actuator are rotatably coupled to the shell, wherein rotation of the actuator relative to the shell Quoted the prosthetic valve move axially through the funnel section make at least part of the prosthetic valve by with institute It states the engagement of funnel section and radial compression, and leaves the crimping device via the outlet.

2. crimping device according to claim 1, further include stick member, the stick member be configured as by The prosthetic valve is resisted against in the shell, wherein the rotation of the actuator causes the stick member relative to the shell Body axial movement, so that the prosthetic valve be pushed to pass through the shell.

3. crimping device according to claim 2, wherein the stick member includes inner cavity, the inner cavity includes multiple vertical To the rib of extension, the rib is configured as contacting the prosthetic valve during radial compression.

4. the crimping device according to any one of claim 2 and 3, wherein the stick member includes annular groove, institute Annular groove is stated to be configured as receiving the end of the prosthetic valve.

5. crimping device described in any one of -4 according to claim 1, wherein the shell includes two or more shells Component, wherein each housing unit includes a part of the funnel.

6. crimping device according to claim 5, further include holding member, the holding member be configured as by The two or more housing units are releasably held together.

7. crimping device according to claim 1 to 6, wherein the rotation of the actuator causes the actuating Device moves axially on the housing.

8. the crimping device according to any one of claim 2-7, wherein the stick member is rotatably coupled to institute Actuator is stated, so that the actuator can be rotated relative to the stick member.

9. the crimping device according to any one of claim 2-7, wherein the stick member include for the cause The releasably locking component that dynamic device releasably engages.

10. a kind of for crimping the crimping device of radially distensible and compression prosthetic valve, the crimping device includes:

Shell, the shell have outlet, and the housing member is configured as receiving the prosthetic valve for being in radial-expansion condition；

Stick member, the stick member can be moved axially relative to the shell, wherein the stick member be configured as to By the end of the prosthetic valve, and the stick member causes the prosthetic valve relative to the axial movement of the shell Radial compression and the prosthetic valve outlet moved axially through with the delivering of radial compression configuration；And

Actuator, the actuator can be rotated relative to the shell and the stick member, to cause the stick member phase The shell is moved axially.

11. crimping device according to claim 10, wherein the inner surface of the shell includes multiple ribs, the multiple rib It is configured as receiving the prosthetic valve for being in radial-expansion condition.

12. crimping device according to claim 11, wherein the stick member further comprises multiple fins, it is described more A fin is arranged between the multiple rib, and is configured as slidably engaging institute during the stick member moves axially State multiple ribs.

13. crimping device described in any one of 0-12 according to claim 1, wherein the housing member also includes to terminate at institute State the conical inboard wall of outlet.

14. crimping device according to claim 13, wherein being moved axially in the stick member relative to the shell Period, the inner wall cause the prosthetic valve radial compression.

15. crimping device described in any one of 0-14 according to claim 1, wherein the stick member is rotatably coupled to The actuator, so that the actuator can be rotated relative to the stick member.

16. a kind of method for crimping prosthetic valve, the method includes:

Shell relative to crimping device rotates the actuator of the crimping device, wherein the shell includes filling with the curling The funnel for the outlet set；And

Slidably engage the prosthetic valve with the funnel, so that at least part radial compression of the prosthetic valve and passing through The crimping device is left by the outlet.

17. according to the method for claim 16, further including the going out from the crimping device by the prosthetic valve Mouth is released and is advanced in the sheath of delivery device.

18. method described in any one of 6-17 according to claim 1, wherein the funnel includes towards the crimping device Multiple ribs that longitudinal axis extends radially inwardly, and for curling the method further includes by the frame of the prosthetic valve At least part be aligned in the multiple rib.

19. method described in any one of 6-18 according to claim 1, wherein the shell includes two or more shell groups Part, each housing unit include a part of the funnel；The method further includes:

The two or more housing units are assembled, and coaxially place the shell before prosthetic valve curling Around delivery device.

20. the two or more housing units of dismounting according to the method for claim 19, are further included, and The two or more housing units are removed from the delivery device.